52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period

Overview[ - collapse ][ - ]

Purpose Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in addition to metformin and compare to sulphonylurea in addition with metformin.
ConditionType 2 Diabetes
InterventionDrug: Metformin
Drug: Sulphonylurea
Drug: Saxagliptin
PhasePhase 3
SponsorAstraZeneca
Responsible PartyAstraZeneca
ClinicalTrials.gov IdentifierNCT00575588
First ReceivedDecember 14, 2007
Last UpdatedMarch 20, 2012
Last verifiedMarch 2012

Tracking Information[ + expand ][ + ]

First Received DateDecember 14, 2007
Last Updated DateMarch 20, 2012
Start DateDecember 2007
Estimated Primary Completion DateAugust 2010
Current Primary Outcome MeasuresHemoglobin A1c (HbA1c) Change From Baseline to Week 52 [Time Frame: Baseline to 52 Weeks] [Designated as safety issue: No]Adjusted mean change from baseline in HbA1c achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Per Protocol Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated as the Week 52 value minus the baseline value.
Current Secondary Outcome Measures
  • Proportion of Participants Reporting at Least One Episode of Any Hypoglycaemic Event Over 52 Weeks [Time Frame: From Baseline to Week 52] [Designated as safety issue: Yes]Proportion of participants reporting at least one episode of any hypoglycaemic event for saxagliptin added on to metformin versus glipizide added on to metformin over 52 weeks (Safety Analysis Set)
  • Body Weight Change From Baseline to Week 52 [Time Frame: Baseline, Week 52 (Last Observation Carried Forward)] [Designated as safety issue: Yes]Adjusted mean change from baseline in Body Weight achieved with saxagliptin added on to metformin versus glipizide added on to metformin at Week 52 (Safety Analysis Set). Body Weight is a continuous measure, the change from baseline for each participant is calculated as the Week 52 (LOCF) value minus the baseline value.
  • Mean Slope of the Regressions of Change From Week 24 to Week 52 in HbA1c [Time Frame: Week 24 to Week 52] [Designated as safety issue: No]Mean slopes of regression of change from Week 24 to Week 52 in HbA1c for saxagliptin added on to metformin versus glipizide added on to metformin (Per Protocol Analysis Set) achieved by fitting a mixed model with subject specific slopes for the time effect (weeks on randomized treatment was utilized). This analysis gives an assessment of the durability of the HbA1c effect.

Descriptive Information[ + expand ][ + ]

Brief Title52-week add-on to Metformin Comparison of Saxagliptin and Sulphonylurea, With a 52-week Extension Period
Official TitleA 52-Week International, Multi-centre, Randomized, Parallel-group, Double-blind, Active-controlled, Phase III Study With a 52-Week Extension Period to Evaluate the Safety and Efficacy of Saxagliptin in Combination With Metformin Compared With Sulphonylurea in Combination With Metformin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Metformin Therapy Alone.
Brief Summary
Saxagliptin is a new investigational medication being developed for treatment of type 2
diabetes. This study is designed to assess the efficacy and tolerability of saxagliptin in
addition to metformin and compare to sulphonylurea in addition with metformin.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionType 2 Diabetes
InterventionDrug: Metformin
open-label metformin
Drug: Sulphonylurea
Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)
Drug: Saxagliptin
Saxagliptin 5 mg tablets
Other Names:
Onglyza
Study Arm (s)
  • Experimental: Saxagliptin
  • Experimental: Glipizide

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment891
Estimated Completion DateAugust 2010
Estimated Primary Completion DateAugust 2009
Eligibility Criteria
Inclusion Criteria:

- Diagnosed with type 2 diabetes,

- Treatment with metformin alone on stable doses of 1500 mg or higher per day for at
least 8 weeks prior to Visit 1,

- HbA1c >6.5% and ≤10.0%

Exclusion Criteria:

- Type 1 diabetes,

- history of diabetic ketoacidosis or hyperosmolar non-ketonic coma,

- Insulin therapy within one year of enrolment (with the exception of insulin therapy
during a hospitalization or use in gestational diabetes)
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesFinland, Germany, Hungary, India, Korea, Republic of, Netherlands, Norway, Russian Federation, Slovakia, United Kingdom, Vietnam

Administrative Information[ + expand ][ + ]

NCT Number NCT00575588
Other Study ID NumbersD1680C00001
Has Data Monitoring CommitteeYes
Information Provided ByAstraZeneca
Study SponsorAstraZeneca
CollaboratorsBristol-Myers Squibb
Investigators Principal Investigator: Burkhard Goke University of Munich, GermanyStudy Director: Peter Ohman, MD AstraZenecaStudy Chair: Deborah Price, MSc AstraZeneca
Verification DateMarch 2012

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Hanko, Finland
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Helsinki, Finland
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Kuopio, Finland
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Kuusankoski, Finland
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Mikkeli, Finland
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Oulu, Finland
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Tampere, Finland
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Aschaffenburg, Germany
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Berlin, Germany
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Dortmund, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hannover, Germany
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Mainz, Germany
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Mannheim, Germany
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Mulheim, Germany
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Pirna, Germany
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Ratzeburg, Germany
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Reinfeld, Germany
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Rhaunen, Germany
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Schmiedeberg, Germany
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Tubingen, Germany
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Wahlstedt, Germany
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Weinheim, Germany
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Balatonfured, Hungary
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Bekescsaba, Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Gyula, Hungary
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Kalocsa, Hungary
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Kaposvar, Hungary
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Kecskemet, Hungary
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Miskolc, Hungary
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Mosonmagyarovar, Hungary
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Nyiregyhaza, Hungary
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Szekesfehervar, Hungary
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Bangalore, Karnataka, India
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Indore, Madhya Pradesh, India
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Mumbai, Mashatra, India
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Jaipur, Rajasthan, India
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Guri, Gyeonggi-do, Korea, Republic of
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Seongnam, Gyeonggi-do, Korea, Republic of
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Wonju, Kangwon-do, Korea, Republic of
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Incheon, Korea, Republic of
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Seoul, Korea, Republic of
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Uijeongbu-si, Korea, Republic of
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Beek En Donk, Netherlands
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Den Bosch, Netherlands
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Den Haag, Netherlands
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Deurne, Netherlands
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Dordrecht, Netherlands
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Losser, Netherlands
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Nijverdal, Netherlands
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Rijswijk, Netherlands
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Roelofarendsveen, Netherlands
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Rotterdam, Netherlands
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Volendam, Netherlands
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Bergen, Norway
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Elverum, Norway
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Flatasen, Norway
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Hamar, Norway
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Honefoss, Norway
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Inderoy, Norway
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Oslo, Norway
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Radal, Norway
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Skedsmokorset, Norway
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Sogndal, Norway
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Spikkestad, Norway
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Trollasen, Norway
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Kazan, Russian Federation
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Moscow, Russian Federation
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Nizhnii Novgorod, Russian Federation
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St. Petersburg, Russian Federation
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Yaroslavl, Russian Federation
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Dolny Kubin, Slovakia
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Kosice - Tahanovce, Slovakia
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Moldava Nad Bodvou, Slovakia
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Ruzomberok, Slovakia
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Trnava, Slovakia
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Zilina, Slovakia
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Annan, Dumfries and Galloway, United Kingdom
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Whitstable, Kent, United Kingdom
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Hamilton, Lanarkshire, United Kingdom
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Salford, Manchester, United Kingdom
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Crawley, West Sussex, United Kingdom
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Bradford-on-avon, Wiltshire, United Kingdom
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Blackpool, United Kingdom
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Coatbridge, United Kingdom
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Coventry, United Kingdom
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Glasgow, United Kingdom
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Motherwell, United Kingdom
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Newcastle, United Kingdom
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Sheffield, United Kingdom
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Ho Chi Minh, Vietnam
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Ho Chi Minh City, Vietnam